PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE

K032942 · Wrp Asia Pacific Sdn. Bhd. · KGO · Dec 17, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032942
• Device Name: PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
• Applicant: Wrp Asia Pacific Sdn. Bhd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Dec 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

Device Story

Sterile, powder-free, polymer-coated polyisoprene surgical glove; worn by surgeons and operating room personnel; acts as a protective barrier to prevent cross-contamination between healthcare personnel and patients; protects surgical wounds from contamination; manufactured from synthetic rubber latex.

Clinical Evidence

No clinical data; bench testing only. Device performance verified against ASTM D 3577-01a (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder-free status), and biocompatibility testing (primary skin irritation and dermal sensitization).

Technological Characteristics

Material: Synthetic rubber latex. Form factor: Surgical glove. Standards: ASTM D 3577-01a (dimensions, physical properties, pinholes), ASTM D 6124-01 (powder content < 2 mg/glove), FDA 21 CFR 800.20. Biocompatibility: Passes primary skin irritation and dermal sensitization tests. Sterilization: Sterile.

Indications for Use

Indicated for use by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, enclosed within a rounded shape. To the right of the logo is the full name of the company, "WRP Asia Pacific Sdn Bhd", also in a bold, sans-serif font. Below the company name is the number "147817 V".

# DEC 1 7 2003

510(k) SUMMARY

K032942

#### 1.0 Submitter:

| Name: | WRP Asia Pacific Sdn Bhd |
|------------|-------------------------------------------------------------------------------------------------------------|
| Address: | Lot 1, Jalan 3, Kawasan Perushaan Bandar Baru Salak Tinggi,<br>43900 Sepang, Selangor Darul Ehsan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: 16 SEP 2003

#### Contact Person: 2.0

| Name: | Mr. Terence Lim |
|------------|-----------------|
| Phone No.: | [phone] |
| Fax No.: | [phone] |

#### 3.0 Name of the device:

| Trade Name: | 1. Profeel, and<br>2. Multiple or Customer's Trade Name |
|----------------------|---------------------------------------------------------------------|
| Device Name: | Powder Free, Polymer Coated Polyisoprene Surgical Glove,<br>Sterile |
| Common Name: | Surgical Gloves |
| Classification Name: | Surgeon's Gloves (per 21 CFR 878.4460) |

#### 4.0 Identification of The Legally Marketed Device:

Class I Powder Free Synthetic rubber latex surgeon's gloves, 79KGO, that meets all
the requirements of ASTM standard D 3577 -- 01a22 Type 2 and FDA 21 CFR 800.20

#### 5.0 Description of The Device:

.

The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, meets all the requirements of ASTM standard D 3577 - 01a52 and FDA 21 CFR 800.20.

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Image /page/1/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a stylized font, with the words "WRP Asia Pacific Sdn Bhd" to the right of the letters. Below the company name is the number 147817V.

K032942

#### Intended Use of the Device: 6.0

The Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile, is made of synthetic rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.

## Summary of The Technological Characteristics of The Device: 7.0

The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, are summarized with the following technological characteristics compared to ASTM or equivalent standards.

| CHARACTERISTICS | STANDARDS | DEVICE<br>PERFORMANCE |
|-----------------------|------------------------------------------|-----------------------------------------|
| Dimensions | ASTM D 3577 - 01aF2 | Meets |
| Physical Properties | ASTM D 3577 - 01aF2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aF2<br>FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | Meets<br>< 2 mg/glove |
| Biocompatability | Primary Skin Irritation in<br>Rabbits | Passes<br>(Not a primary skin irritant) |
| | Dermal Sensitization | Passes<br>(Not a contact sensitizer) |

## Substantial Equivalent Based on Assessment of Non-Clinical Performance Data 8.0

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above.

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Image /page/2/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font inside of a black oval. To the right of the logo is the text "WRP Asia Pacific Sdn Bhd" in a similar font. Below the text is the number "147817V".

Image /page/2/Picture/1 description: The image shows a sequence of handwritten characters. The characters are 'K032942'. The characters are written in a cursive style, with some of the characters connected to each other. The image is a close-up of the characters, and the background is white.

# Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0

Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

#### Conclusion 10.0

It can be concluded that the Powder Free, Polymer Coated Polyisoprene Surgical Glove, Sterile will perform according to the glove performance standards referenced in section 7 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2003

Mr. Terence Lim Associate Manager, Quality Assurance Regulatory Affairs WRP Asia Pacific Sdn Bhd Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang, Selangor Darul Ehsan MALAYSIA

Re: K032942

Trade/Device Name: Profeel and Multiple Customer's Trade Names, Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: September 16, 2003 Received: September 22, 2003

Dear Mr. Lim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lim

Please be advised that FDA's issuance of a substantial equivalence determination does not r lease that FDA has made a determination that your device complies with other requirements mount that 1 Dr. Mar in and regulations administered by other Federal agencies. of the Flor of arry a vith all the Act's requirements, including, but not limited to: registration 1 ou intest comply with a807); labeling (21 CFR Part 801); good manufacturing practice and ilsuing (2 = set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a premainten libated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ches

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for WRP Asia Pacific Sdn Bhd. The logo consists of the letters "WRP" in a bold, sans-serif font, with the letters arranged in a slightly curved shape. To the right of the logo is the company name, "WRP Asia Pacific Sdn Bhd," in a smaller, sans-serif font. Below the company name is the number "147817V".

# INDICATIONS FOR USE

Applicant: WRP Asia Pacific Sdn Bhd

510(k) Number (if known): K032942

Device Name: PROfeel and Multiple Customer's Trade
Names, POWDER FREE, POLYMER COATED
POLYISOPRENE SURGICAL GLOVES,
STERILE

Indications For Use:

The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Martha T. O'Lone

510(k) Number: K032942

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc (Per 21 CFR 801.109) OR

Over-The-Counter ✓